Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

Official title:

Physical Activity Level of Norwegian Boys With Duchenne Muscular Dystrophy - a Cross Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947112
• Other study ID #: 2019/260
• Status: Completed
• Start date: August 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this population based study is to examine, quantify and describe physical activity level in Norwegian boys with DMD, and to compare the level of physical activity level between boys with DMD and age matched healthy boys. A co-project will validate ActiGraph accelerometry to measure physical activity in boys with DMD.

Description:

International guidelines recommend regular physical activity for boys with DMD, and participation in physical activity plays a key role in the management. Paradoxically, patients with severe neuromuscular disease like DMD, have considerable limitations to participate in such activities. Limitation may be muscle weakness, pain, fatigue, reduced mobility and overall function, and also limited knowledge of physical activity benefits among health care personnel. Limited participation leads to a sedentary lifestyle, and gradual under-use of still functioning muscles may cause secondary deterioration in DMD. The current physical activity level amongst Norwegian DMD's are unknown, and physical activity registration and self-reported questionnaire will be examined in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Boys with conclusive diagnosis of Duchenne Muscular disease, attending Norwegian pediatric rehabilitation clinics.
• Signed written consent
• Able to answer questionnaires with help from parents, care giver(s) or health care professional with regular follow up of the participants.

Exclusion Criteria:

• Lack of consent.
• Language difficulties
• Cognitive dysfunction or mental retardation leading to difficulties in answering the questionnaires adequately

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Behavioral:
• Physical activity registration
At start, participants and parents fills out a Self-report questionnaire and the UngKan-3 Questionnaire, before a seven day physical activity registration takes place by use og ActiGraph. A physical activity diary are filled out every evening while the physical activity registration takes places.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Norwegian School of Sport Sciences, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Birnkrant DJ, Bushby K, Bann CM, Apkon SD, Blackwell A, Brumbaugh D, Case LE, Clemens PR, Hadjiyannakis S, Pandya S, Street N, Tomezsko J, Wagner KR, Ward LM, Weber DR; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol. 2018 Mar;17(3):251-267. doi: 10.1016/S1474-4422(18)30024-3. Epub 2018 Feb 3. Review. Erratum in: Lancet Neurol. 2018 Apr 4;:. — View Citation

Heutinck L, Kampen NV, Jansen M, Groot IJ. Physical Activity in Boys With Duchenne Muscular Dystrophy Is Lower and Less Demanding Compared to Healthy Boys. J Child Neurol. 2017 Apr;32(5):450-457. doi: 10.1177/0883073816685506. Epub 2017 Jan 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity diary	During physical activity registration with use of ActiGraph monitor, the participants and parents are asked to fill out a diary, describing type of physical activity been performed, for how long the physical activity was performed, how tired the participants became, and how did the participant enjoy the activity being performed. In addition the participants is asked to give a summary of the week regarding to name the most enjoyable activity this week and the reason why, and to describe if there occurred something unusual that increased or decreased their physical activity level more than regular.	Day 1
Primary	Physical activity registration	An Actigraph will be provided and worn at pre set time frame (Seven days including weekend). Data extracted are counts per minutes, and are measurements of movement performed in both vertical and horizontal axis. The counts will be used to quantify the time the participant is inactive, low, moderate and / or in vigorous physical active.	Seven days
Secondary	Leisure time physical activity	The UngKan-3 questionnaire is a self-reported/parent-reported instrument, developed to measure leisure time physical activity, diet, media habits and sleep routine. The questionnaire is former used in a national cross-sectional survey amongst Norwegian school students, developed by the Norwegian School of Sport Sciences and Norwegian Institute of Public Health.	Day 1
Secondary	Self-Reported Questionnaire	Self-administrated questionnaire developed to describe participants function, on-going treatment, movement aid, types of physical activities	Day 1